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Phase IIb Study to Study the Efficacy of AT1001 to Treat Celiac Disease

This study has been completed.
Sponsor:
Information provided by:
Alba Therapeutics
ClinicalTrials.gov Identifier:
NCT00492960
First received: June 25, 2007
Last updated: January 18, 2010
Last verified: January 2010

June 25, 2007
January 18, 2010
August 2007
October 2008   (final data collection date for primary outcome measure)
To evaluate the efficacy of multiple dose levels of AT-1001 in preventing intestinal permeability changes induced by a 6- week gluten challenge. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy of multiple dose levels of AT-1001 in preventing intestinal permeability changes induced by a 6- week gluten challenge.
Complete list of historical versions of study NCT00492960 on ClinicalTrials.gov Archive Site
  • To prospectively validate a composite, weighed index of celiac disease activity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Monitoring of adverse events (AEs) including signs and symptoms of gluten toxicity, Vital signs, Physical exam findings, EKG, Pregnancy Screening, Clinical laboratory testing of chemistry, hematology, and urinalysis specimens [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
To prospectively validate a composite, weighed index of celiac disease activity
Not Provided
Not Provided
 
Phase IIb Study to Study the Efficacy of AT1001 to Treat Celiac Disease
A Phase IIb, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of AT-1001 in Celiac Disease Subjects During a Gluten Challenge

This study will look at 3 doses of AT1001 for efficacy and safety for the treatment of celiac disease.

The primary efficacy outcome is to evaluate the efficacy of multiple dose levels of AT-1001 in preventing intestinal permeability changes induced by a 6- week gluten challenge.

This is an outpatient, randomized, double blind multicenter study. Subjects will remain on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules will be administered TID 15 minutes before each meal (breakfast, lunch, and dinner). Gluten or gluten placebo capsules will be taken TID with each meal.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Celiac Disease
  • Drug: AT-1001
    capsules, TID
  • Drug: placebo
    capsules, TID
  • Experimental: 1
    AT-1001 capsules 1 mg with 900mg gluten
    Intervention: Drug: AT-1001
  • Experimental: 2
    AT-1001 capsules 4 mg with 900 mg gluten
    Intervention: Drug: AT-1001
  • Experimental: 3
    AT-1001 capsules 8 mg with 900 mg gluten
    Intervention: Drug: AT-1001
  • Placebo Comparator: 4
    Drug placebo capsules with 900 mg gluten
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
184
March 2009
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

Eligible subjects must meet all of the following criteria before being enrolled into the study:

  1. Age between 18 and 72 years, inclusive.
  2. Diagnosed with celiac disease for more than 6 months.
  3. Anti-Tissue Transglutaminase (anti-tTG) less than 10 EU.
  4. On a gluten-free diet for at least 6 months.
  5. BMI between 18.5 and 38, inclusive.

Exclusion Criteria

Subjects meeting any one of the following criteria are not eligible for the study:

  1. Current smoker.
  2. Has chronic active GI disease other than celiac disease (e.g. Crohn's, Colitis).
  3. Has diabetes (Type 1 or Type 2).
  4. Unable to abstain from alcohol consumption for 48 hours prior to each intestinal permeability collection throughout the study.
  5. Unable to refrain from consuming non-steroidal anti-inflammatory agents, including aspirin ("NSAIDs") for 48 hours prior to each intestinal permeability collection throughout the study.
  6. Participated in any clinical drug study within the past 30 days or has had previous exposure to AT-1001.
  7. Presents with or has a history of dermatitis herpetiformis.
Both
18 Years to 72 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00492960
CLIN1001-006
No
Francisco Leon, Executive Director of Medical Affairs, Alba Therapeutics
Alba Therapeutics
Not Provided
Study Director: Francisco Leon, MD, Ph.D. Alba Therapeutics Corp
Alba Therapeutics
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP